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IRCT20201028049175N1 IRCT 2020-12-12 Arak University of Medical Sciences EVALUATION OF THE EFFECT OF FAVIPIRAVIR ON MANAGEMENT PATIENT WITH COVID-19 COVID-19 EVALUATION OF THE EFFECT OF FAVIPIRAVIR ON MANAGEMENT PATIENT WITH COVID-19 2020-11-21 anticipated 114 Complete https://irct.ir/trial/51946 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method, Blinding description: In this study patients are blind, as one group will receive Favipiravir and control group will receive flour tablet that is similar to Favipiravir.In addition, data analyser is blind about groups of patients. 3 Coronavirus disease 2019 (COVID19). Intervention 1: Intervention group: Favipiravir tablet of FUJIFILM company will be given to the patients. The dose is 1600 mg twice daily on first day and days 2–7: 600 mg twice daily. Intervention 2: Control group: Placebo drug (flour tablet) will be given to the patients orally twice daily for 7 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are no more data.
public Behnam Mahmoudieh
Valiasr hospital, Valiasr square
Arak Iran (Islamic Republic of) 3814957558 086-32222003-8 behnammahmoodiyeh@gmail.com Arak University of Medical Sciences scientific Alireza Kamali
Valiasr hospital, Valiasr square
Arak Iran (Islamic Republic of) 3814957558 086-32222003-8 alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) All of patients with COVID19 referred to Valiasr and Khansari hospital All of patients in subgroup 3 of hospitalization no limit no limit Both Patients that present allergic reaction to the drug Patients with deterioration of symptomps after drug usage Renal failure manifestation in patients Heart failure manifestation in patients Pregnancy U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: Favipiravir tablet of FUJIFILM company will be given to the patients. The dose is 1600 mg twice daily on first day and days 2–7: 600 mg twice daily. Control group: Placebo drug (flour tablet) will be given to the patients orally twice daily for 7 days. Severity of coronavirus 2019. Timepoint: Before prescription of drug and then every day until 7 days. Method of measurement: pulse oximetry, resspiratory rate, heart rate, CT scan. Arak University of Medical Sciences Approved 2020-08-02 Ethics committee of Arak University of Medical Sciences Assistance of research and technology, Payambare azam institution, Arak University of Medical Sciences, Sardasht street Arak Markazi Iran (Islamic Republic of)